Dental Solder Alloy
FDA 510(k) K920060 · Deringer-Ney, Inc.
510(k) numberK920060
Submission
- Device name
- Dental Solder Alloy
- Applicant
- Deringer-Ney, Inc.
Bloomfield, CT, US - Received
- January 6, 1992
- Decision date
- April 2, 1992
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Other 510(k)s with product code EJT
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K052463 | Prometal HN86EJT · Traditional | Prometal Technologies | 10/14/2005SE |
| K041378 | Bio 60EJT · Traditional | Kodent, Inc. | 08/02/2004SE |
| K040672 | Porta ReflexEJT · Traditional | Wieland Dental + Technik GmbH & Co. KG | 05/27/2004SE |
| K040524 | Porta Solder 1090 WEJT · Traditional | Wieland Dental + Technik GmbH & Co. KG | 05/20/2004SE |
| K040043 | NDX-40 AlloyEJT · Traditional | Heraeus Kulzer, Inc. | 03/03/2004SE |
| K034049 | Herador Ec, PF, C, H, NH, G, GG and MP; Heraloy U and G; Herabond N; Albabond C, B and…EJT · Traditional | Heraeus Kulzer,GmbH | 03/01/2004SE |
| K033279 | Gold Dental Casting AlloysEJT · Traditional | Bego U.S.A. | 01/15/2004SE |
| K033446 | APEX93, APEX87, APEX84, APEX85, APEX77, E-Sarang 88 and E-Sarang 82EJT · Traditional | We Dong Myung Dental Industrial Co., Ltd. | 11/13/2003SE |
| K033435 | E-Sarang 86, DM78, DM55EJT · Traditional | We Dong Myung Dental Industrial Co., Ltd. | 11/12/2003SE |
| K032320 | Appollo 3 AlloyEJT · Traditional | Dentsply International | 10/01/2003SE |
More from Dentsply International
| 510(k) | Device | Decision |
|---|---|---|
| K933178 | GDC 3509EJT · Traditional | 10/14/1993SE |
| K930482 | Dental Casting Alloy, Modification - PF-3EJT · Traditional | 03/31/1993SE |
| K930481 | Dental Casting Alloy MODIFICATION-PF-4EJT · Traditional | 03/31/1993SE |
| K925273 | GDC 3445EJS · Traditional | 12/21/1992SE |
| K920922 | GDC 3367EJS · Traditional | 05/05/1992SE |
| K920887 | GDC-3338, Dental Solder AlloyEJS · Traditional | 03/19/1992SE |
| K910065 | GDC-3200 Dental SolderEJT · Traditional | 03/15/1991SE |
| K904695 | GDC-1501EJT · Traditional | 01/02/1991SE |
| K904614 | GDC-1475EJT · Traditional | 12/19/1990SE |
| K901532 | GDC 3084 Casting AlloyEJT · Traditional | 05/02/1990SE |
Questions and answers
When was Dental Solder Alloy cleared by the FDA?
Dental Solder Alloy (K920060) received a 510(k) decision of Substantially Equivalent on April 2, 1992, 87 days after the submission was received.
What is the product code of K920060?
The FDA product code is EJT – Alloy, Gold-Based Noble Metal, a Class II (moderate risk) device regulated under 21 CFR 872.3060.